[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pharmacokinetics-and-pharmacodynamics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pharmacokinetics-and-pharmacodynamics":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644876","phase-4-efficacy-and-safety-of-eleveld-pkpd-model-based-dosing-during-general-anesthesia-100644876",false,"NCT07675850","Efficacy and Safety of Eleveld PK\u002FPD Model-based Dosing During General Anesthesia","Comparison of Efficacy and Safety Between Eleveld PK\u002FPD Model-based Dosing and Standard Dosing During General Anesthesia","Inclusion Criteria:\n\n* Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation\n\nExclusion Criteria:\n\n* Emergency surgery\n* Surgery requiring evoked potential (EP) monitoring\n* Chronic benzodiazepine users\n* Body Mass Index (BMI) ≥ 35 kg\u002F㎡\n* Chronic kidney disease\n* Hepatic dysfunction or chronic liver disease\n* Contraindication or history of hypersensitivity to remimazolam\n* American Society of Anesthesiologists (ASA) physical status ≥ IV\n* Pregnant women\n* Contraindication or history of hypersensitivity to flumazenil","ALL","19 Years","79 Years",{"count":20,"type":21},68,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic\u002Fpharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.\n\nThe main questions it aims to answer are:\n\nDoes Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?\n\nCan the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?\n\nResearchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.\n\nParticipants will:\n\n* Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen.\n* Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor.\n* Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).",[27,28],"Remimazolam","Pharmacokinetics and Pharmacodynamics",[27,30,31],"general anesthesia","pharmacokinetics and pharmacodynamics","NOT_YET_RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":21},"2026-07-30",{"date":40,"type":21},"2027-05-31",{"name":42,"class":43},"Seoul National University Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":44},"100592454","pharmacometrics-analysis-of-rivaroxaban-in-chinese-children-aged-over-2-years-100592454","NCT06993636","Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years","Population Pharmacokinetic\u002FPharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease","Inclusion Criteria:\n\n1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;\n2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;\n3. Children aged 2 years to \\\u003C18 years\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n3. Patients participating in clinical trials of other drugs at the same time","2 Years","18 Years",{"count":55,"type":21},60,"OBSERVATIONAL","Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic\u002Fpharmacodynamic analysis",[59,60,61,62,28],"Kawasaki Disease","Coronary Artery Aneurysm","Rivaroxaban","Anticoagulant Drugs",[64,65,66,67,68],"Kawasaki disease","Coronary artery aneurysm","Population pharmacokinetic and pharmacodynamic","rivaroxaban","anticoagulant","RECRUITING","2025-05-25",{"date":72,"type":36},"2025-05-29",{"date":74,"type":36},"2023-01-01",{"date":76,"type":21},"2026-12-31",{"name":78,"class":43},"Children's Hospital of Fudan University"]